Pharmacokinetics Clinical Trial
Official title:
A Clinical and Pharmacokinetic Study to Evaluate the Influence of Two Bupivacaine Concentrations on Peak Plasma After Ultrasound-guided Axillary Brachial Plexus Block
Introduction: The risk of systemic toxicity when using bupivacaine is a persistent problem,
making its pharmacokinetic study crucial to the safety of regional anesthesia (RA). Little
evidence exists regarding the effect of different concentrations of this drug on peak plasma
levels. The present study compares two bupivacaine concentrations to establish how the
concentration and exchange area affect the peak plasma level of this drug during axillary
brachial plexus block. Latency and postoperative analgesia periods were also compared.
Methods: 32 patients were randomly assigned to two groups. In the 0.25% group, 10 ml of
0.25% bupivacaine was injected per nerve; in the 0.5% group, 5 ml of 0.5% bupivacaine was
injected per nerve. Peripheral blood samples were collected every 15 min during the first
hour and every 30 min during the second hour to establish serum level dosage.
High-performance liquid chromatography coupled with mass spectrometry was used for the
analysis.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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